BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X10

    MDR report key: 8372109 · Received February 26, 2019

    Report

    Report Number
    3008261720-2019-00787
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 26, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023395
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE (DESCRIPTION): 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT. JJGC CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE (DESCRIPTION) IN F10: 1690/ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 14 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE II BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, AND INSUFFICIENT BONE QUALITY/QUALITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. RP.017758.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 14 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE II BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, AND INSUFFICIENT BONE QUALITY/QUALITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165401 CM DRIVE IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800310089I 07899878023395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention